Obesity Surgery, Counseling, and Psychological Well-Being
Primary Purpose
Obesity, Bariatric Surgery
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Group Counseling
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric surgery, Binge Eating Disorder, Psychological Health, Counselling
Eligibility Criteria
Inclusion Criteria:
- Patients registered for bariatric surgery
Exclusion Criteria:
- Not applicable
Sites / Locations
- Jordan HospitalRecruiting
- SKMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group Counseling
Standard treatment
Arm Description
The major aim of the post-operative counseling groups is to engage patients in discussing and exchanging their thoughts on issues of concern related to their surgery and overall well-being. The selected patients will be informed about the purpose of these support groups and will be made aware that their attendance is entirely voluntary.
Outcomes
Primary Outcome Measures
weight loss
Body weight will be measured in regular intervals to record weight loss.
psychological health
A set of standardized measures is being used to assess participants' psychological health including the following:
Three Factor Eating Questionnaire, Binge Eating Scale, Parts of Bulimic Investigatory Test, Beck Depression Inventory (revised), Zung Anxiety Scale, Rosenberg Self-Esteem Scale, Experience of Shame Scale, Obsessive-Compulsive Inventory, Parts of Eating Disorders Quality of Life Scale and the Mini Mental State Examination.
Secondary Outcome Measures
Full Information
NCT ID
NCT01865227
First Posted
May 27, 2013
Last Updated
June 13, 2013
Sponsor
American University of Sharfah
Collaborators
Sheikh Khalifa Medical City, Jordan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01865227
Brief Title
Obesity Surgery, Counseling, and Psychological Well-Being
Official Title
Impact of Counseling on Obesity Surgery Outcomes and Psychological Functioning: A Randomized Clinical Trial in 2 Arab Countries
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Sharfah
Collaborators
Sheikh Khalifa Medical City, Jordan Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity has become a global epidemic causing enormous human and economic costs. Incidence rates have doubled over the last few decades and obesity-related illnesses such as diabetes and cardiovascular diseases now constitute one of the major contributors to the global burden of disability. Overall, obesity has been recognized as one of the most pressing public health concerns worldwide and effective treatment and prevention strategies are urgently required. While behavioral and pharmacological treatments (e.g.low calorie diets, medication) are successful means for overcoming overweight and mild obesity, more severe cases of obesity usually fail to respond to such interventions. As a result, the demand for weight loss surgery is growing among this population. However, uncertainties about the effectiveness of obesity surgery persist and high relapse rates (i.e. weight regain) are common. Further research in this field is needed to identify risk factors that may trigger relapse and to understand patients' treatment needs in greater depth. Previous studies have pointed toward high levels of mental health problems among patients. However, the impact of preoperative psychopathology on actual surgery outcomes remains unclear. Similarly, few studies have investigated the effect of postoperative therapy on patients' psychological functioning and weight loss patterns. Research addressing these gaps is imperative to establish best-practice approaches. This challenge applies in particular to Middle East and North Africa(MENA) countries where research in the field of bariatric surgery and related mental health is largely missing. This is a major concern given the fact that the MENA region experienced the highest increase in overweight and obesity in recent decades compared to other countries.
The proposed study aims to address this deficiency by examining obesity surgery patients in two Arab countries (UAE and Jordan). The goals of the project are to investigate the nature and extent of psychological health concerns among these patients before and after surgery and potential associations with treatment outcomes. Moreover, it will test the efficacy of post-operative counseling to improve weight loss and psychological health. For this purpose, a randomized clinical trial design will be employed so that cause and effect relationships between postoperative counseling and treatment outcomes(i.e. weight loss and psychological functioning) can be examined experimentally. The study will start by assessing participants' psychological health prior to surgery by using standardized self-report measures.
After surgery, participants will be randomly assigned to either the intervention condition consisting of 3-monthly post-operative medical checkups plus group counseling or the treatment as usual condition (i.e. 3-monthly standard medical checkups only). Additionally, participants' psychological health will be reassessed in both groups at 3, 6, 9 and 12 months after surgery. The benefit of the experimental study design is that it allows comparing patient outcomes between groups while at the same time controlling for a wide range of potential confounding variables.
The data collected are expected to make a significant contribution to the treatment challenge of one of the most pressing public health concerns worldwide. Study results will add to clinical practice by broadening and deepening our knowledge of the treatment needs of obese patients. By identifying psychological health concerns that may threaten successful treatment outcomes high-risk patient groups can be recognized early, which in turn may help to reduce postoperative weight regain and other complications.
To the best of the PI's knowledge, the proposed work would be the first study of this kind in the Arab world. Findings will be helpful for developing culturally sensitive and evidence-based best-practice guidelines, which are vital to achieve satisfying long-term outcomes. Moreover, study results will be relevant for research communities and practitioners outside the MENA region since empirical support for the effectiveness of obesity surgery remains weak internationally.
Detailed Description
Obesity has become a global epidemic causing enormous human and economic costs. According to the World Health Organization in 2011 overweight and obesity represent the fifth leading risk of death globally, with 2.8 million adults dying each year as a result of excess weight. Worldwide, estimates of overweight and obesity have reached 1.5 billion and 500 million respectively. In addition to an overall increased mortality among this population, a large body of evidence has shown that excess weight is linked to several chronic illnesses including cardiovascular diseases (e.g. stroke), diabetes mellitus (type 2), certain cancers (e.g. breast and colon cancer) and osteoarthritis. Furthermore, obesity inflicts major economic losses. Past research has confirmed that obesity is associated not only with higher medical expenditures due to greater usage of medical services but also with increased non-medical costs, for example due to absenteeism from work.
While the continuous rise of overweight and obesity is a major concern globally, it has reached particular urgency in the MENA region where prevalence rates of both conditions have risen to alarming levels. For example, two recent systematic literature reviews focusing on the Arabian Gulf States reported overweight and obesity rates from 25 to 48% and 13 to 49% respectively across the six countries. UAE-specific data showed obesity rates ranging from 26 to 47%. Additionally, the authors identified the UAE as the Gulf state with the highest hypertension and diabetes rates. In fact, the 2011 UAE diabetes figure of 19% has been confirmed to be one of the highest in the world. When looking at MENA countries outside the Gulf, the highest obesity rates were reported for Syria and Jordan (38% and 35%, respectively).
In order to tackle the increasing burden of obesity, effective intervention and prevention approaches are required. While behavioral and pharmacological treatments (e.g. low calorie diets, exercise, medication) are successful means for overcoming overweight and mild obesity, cases of more severe obesity usually fail to respond to such interventions. Instead, more radical measures such as bariatric surgery are typically needed to achieve substantial weight loss. Past research has shown that most patients lose significant amounts of weight after surgery. However, weight loss maintenance remains problematic with weight regain and other adjustment difficulties (e.g. adapting healthy eating behaviors) being common. Yet, little is known about the risk factors that may trigger weight relapse. Previous research in this context has pointed toward high levels of mental health problems among obese individuals including bariatric surgery patients. Affective, anxiety and eating disorders (in particular binge eating symptoms) were most commonly reported with prevalence rates reaching up to 84%. However, the impact of preoperative psychopathology on actual surgery outcomes is not well understood. Results remain inconsistent and further research is needed to determine whether or not psychological factors jeopardize successful surgery outcomes. Another important question in this regard is whether postoperative interventions that focus on patients' psychological health are helpful in sustaining the achieved weight loss and in coping with postoperative adjustment difficulties. Until now, only few empirical studies have addressed this question. Findings so far indicated a positive impact of postoperative counseling on patients' weight management and overall well-being. However, small sample sizes, differences in study methodology (e.g. qualitative vs. quantitative), and the diversity of therapeutic interventions provided impede any firm conclusions.
In addition to these uncertainties, it is important to recognize that research in the field of bariatric surgery and mental health has been almost entirely restricted to Western countries. Despite repeated searches of several databases (e.g. PsycInfo, Academic Search Premier, and Medline) and examination of bibliographies of relevant papers no matching studies from MENA countries could be found. This lack of regional data is a major concern given the difficulty of generalizing findings cross-culturally on the one hand and the high obesity rates in this part of the world on the other. MENA-based research in this field would yield vital insights for policy makers, commissioners and practitioners in the management and delivery of evidence-based best-practice and patient-oriented care.
Therefore, the proposed study aims to:
Examine psychological health before and after bariatric surgery among obese patients in the UAE and Jordan
Investigate the impact of patients' psychological health on postoperative weight loss, and
Assess the efficacy of group-based counseling to improve patient outcomes (i.e. weight loss and psychological health) after bariatric surgery
The study hypotheses are as follows:
Participants with higher levels of psychological health problems before surgery will lose less weight (in %) during the first 12 months after surgery than patients with lower levels of psychological health problems.
Participants who receive postoperative counseling in addition to standard treatment will lose more weight (in %) during the first 12 months after surgery than patients who are provided with standard treatment only.
Participants who receive postoperative counseling in addition to standard treatment will show less psychological health problems at 12 months after surgery than patients who are provided with standard treatment only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery
Keywords
Obesity, Bariatric surgery, Binge Eating Disorder, Psychological Health, Counselling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Counseling
Arm Type
Active Comparator
Arm Description
The major aim of the post-operative counseling groups is to engage patients in discussing and exchanging their thoughts on issues of concern related to their surgery and overall well-being. The selected patients will be informed about the purpose of these support groups and will be made aware that their attendance is entirely voluntary.
Arm Title
Standard treatment
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Group Counseling
Primary Outcome Measure Information:
Title
weight loss
Description
Body weight will be measured in regular intervals to record weight loss.
Time Frame
12 months
Title
psychological health
Description
A set of standardized measures is being used to assess participants' psychological health including the following:
Three Factor Eating Questionnaire, Binge Eating Scale, Parts of Bulimic Investigatory Test, Beck Depression Inventory (revised), Zung Anxiety Scale, Rosenberg Self-Esteem Scale, Experience of Shame Scale, Obsessive-Compulsive Inventory, Parts of Eating Disorders Quality of Life Scale and the Mini Mental State Examination.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients registered for bariatric surgery
Exclusion Criteria:
Not applicable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Tahboub-Schulte, PhD
Phone
00971508829098
Email
stahboubschulte@aus.edu
Facility Information:
Facility Name
Jordan Hospital
City
Amman
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bashir
Email
ahmad.bashir.md@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmad Bashir
Facility Name
SKMC
City
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrahman Nimeiri
First Name & Middle Initial & Last Name & Degree
Abdelrahman Nimeiri
12. IPD Sharing Statement
Learn more about this trial
Obesity Surgery, Counseling, and Psychological Well-Being
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